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Canagliflozin-Mealtime Insulin Rescue
24-week, randomized, double blind, placebo-controlled trial to evaluate safety and efficacy of canagliflozin as compared with placebo in reducing the need for mealtime insulin in subjects with type 2 diabetes currently using a basal-bolus insulin regimen.
Details
| Lead sponsor | Foundation for Atlanta Veterans Education and Research, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 40 |
| Start date | 2016-01 |
| Completion | 2022-12 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- canagliflozin
- placebo
Primary outcomes
- Number of patients who discontinue all pre-meal medications for at least one meal per day — 24 weeks
- Number of patients who replace mealtime insulin with an oral agent for at least one meal per day — 24 weeks
anti-hyperglycemic pill instead of insulin for at least one meal per day - Number of patients with a continuing need for insulin 4 times per day — 24 weeks
no change from the original basal -bolus regimen - Frequency and severity of hypoglycemia — 24 weeks
Hypoglycemic episodes will be evaluated using a hypoglycemia questionnaire - Self monitoring and continuous monitoring blood glucose levels — 24 weeks
glycemic control and glycemic variability
Countries
United States